Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01367561

Enrollment

Registered

2011-06-07

Start date

2002-10-31

Completion date

2003-05-31

Last updated

2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Males

Brief summary

This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.

Interventions

DRUGNaloxone

DRUGIV Methylnaltrexone (MNTX)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy males, 18 to 65 yrs with normal urinary function 2. Body weight less than 150 kg and Body Mass Index between 20-32.

Exclusion criteria

1. Females 2. History of drug or alcohol abuse 3. History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.) 4. Subjects who received opioids for one week or longer in the last 2 months.

Design outcomes

Primary

Measure	Time frame	Description
Maximal force of detrusor contraction (Pdet) after administration of MNTX	14 days	To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026